Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis

Colon Cancer Liver Metastasis Clinical Trial

Official title:

An Observational Study of TACE Hepatic Arterial Infusion of Oxaliplatin, Irinotecan and Raltitrexed Treatment for Refractory Liver Metastasis From Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631564
• Other study ID #: Ral-1
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2015
• Last updated: December 14, 2015
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Fudan University
• Contact: Bo Zhou, M.D, Ph.D
• Phone: 8621-18616880602
• Email: bonheurzhou[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.

Description:

Colorectal cancer is one of most popular cancer worldwide. Patients with liver metastasis have poor prognosis except for curative resection. Chemotherapy combined biologic agents have improved mCRC median progress free survival and median overall surivival, but it is difficult to deal with liver lesions after FOLFOX and FOLFIRI treatments failed. We aim to observe the safety and efficacy of hepatic infusion and embolization of oxaliplatin, irinotecan and raltitrexed treatment for refratory liver metastasis from colorectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist

• Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy

• Liver disease must not be amenable to potentially curative surgical resection

• Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months

• Patients must have a patent portal vein as documented by CT, MRI, or ultrasound

• Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study

• Eastern Cooperative Oncology Group performance status 0-1

• Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded

• Life expectancy of >= 12 weeks

• Leukocytes >= 3,000/uL

• Absolute neutrophil count >= 1,500/uL

• Platelets >= 100,000/uL

• Total bilirubin =< ULN

• AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =< 2.5 X institutional ULN

• Creatinine < 2.0 mg/dL

• PT/PTT < 1.5 X ULN

• Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential

• Patients must demonstrate ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days

• Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents

• Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events

• As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible

• Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin

• Patient with significant cardiac, renal or hematologic or pulmonary dysfunction

• Patients with previous chemoembolization to liver metastases Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of adverse events		6 months	Yes
Secondary	Overall survival		2 years	No
Secondary	Time to progression		one year	No